BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2231305 · Received July 25, 2011

    Report

    Report Number
    1717344-2011-00609
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    May 23, 2001
    Report Date
    July 20, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CYSTECTOMY/ILEAL CONDUIT, THE KNIFE BECAME MISALIGNED. THE SURGEON OPENED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. THE DEVICE WAS RETURNED WITH THE KNIFE BLADE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK